BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE— 510(k) K053443
Substantially EquivalentRegent Medical Americas, LLC
FDA 510(k) clearance K053443 for BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE, Substantially Equivalent on 2006-02-01. Applicant: Regent Medical Americas, LLC.
Clearance details
- Applicant
- Regent Medical Americas, LLC
- Product code
- Code KGO
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norcross, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.